The following data is part of a premarket notification filed by Aerogen, Inc. with the FDA for Aeroneb Ii, Model Apn 200.
| Device ID | K992831 |
| 510k Number | K992831 |
| Device Name: | AERONEB II, MODEL APN 200 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN, INC. 1310 Orleans Dr. Sunnyvale, CA 94089 |
| Contact | Traci V. A Edwards |
| Correspondent | Traci V. A Edwards AEROGEN, INC. 1310 Orleans Dr. Sunnyvale, CA 94089 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1999-08-23 |
| Decision Date | 2000-08-25 |
| Summary: | summary |